BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2831355 · Received November 14, 2012

    Report

    Report Number
    1226420-2012-00064
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 28, 2012
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ROOT CAUSE: THE P2 IS A ELECTROSURGICAL DEVICE AND AS SUCH IS CONSIDERED AN INTENTIONAL RADIATOR OF RF ENERGY WHEN KEYED VIA FOOTSWITCH OR HANDPIECE BUTTON. ALL EQUIPMENT IN THE OR SHOULD BE DESIGNED TO WITHSTAND THE EMI INTERFERENCE GENERATED BY THE P2 RF GENERATOR PER IEC 60601 REQUIREMENTS. THE P2 IS FUNCTIONING AS DESIGNED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. (B)(4).

    Description of Event or Problem · 1

    GENERATOR INTERFERENCE WITH ANESTHESIA MACHINE. NO PATIENT INJURIES.

    Description of Event or Problem · 1

    GENERATOR INTERFERENCE WITH ANESTHESIA MACHINE. NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR II GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1